EMERGO SUMMARY OF KEY POINTS:

• Chinese regulators have identified the first 10 medical device clinical trial sites to undergo CFDA inspections.
• So far, the new CFDA inspection program focuses primarily on clinical trials for domestic registrants.
• Foreign device registrants may undergo CFDA inspections with more frequency as the program continues.

Following its recent announcement of a new inspection program for medical device clinical trial sites, the China Food and Drug Administration (CFDA) has identified the first round of sites that will undergo such inspections.

The CFDA has issued a list of 10 devices (link in Chinese) currently undergoing clinical trials in China as part of their market registration efforts. According to Emergo sources in Hong Kong, the registrations in question are from eight domestic medical device manufacturers, one domestic IVD manufacturers and one foreign manufacturer of a DNA sequencing device. Half of these devices are implantable.

Companies whose registrations have been identified will be notified separately as to when CFDA officials will conduct their clinical trial site inspections; whether Chinese regulators will make this information public remains to be seen.

Emergo will report on additional details of the new CFDA clinical trial inspection program—including to what extent foreign manufacturers and sponsors are affected—as we learn them.

Additional Chinese medical device market resources from Emergo:

• CFDA registration and approval support for medical device and IVD companies
• CFDA clinical and testing requirements assessment services
• Clinical trial data management support
• China regulatory process chart